Label: AMERICAN SAFETY FIRST AID- lidocaine hcl spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 15, 2024

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  • Active ingredient

    Lidocaine HCL 2%

  • Purpose

    External analgesic

  • Uses

    for the temporary relief of pain associated with minor burns

  • Warnings

    For external use only

  • Do not use

    in large quantities, particularly over raw surfaces or blistered areas

  • When using this product

    avoid contact with the eyes

  • Stop use and ask a doctor if

    • condition worsens
    • symptoms persist more than 7 days
    • condition clears up and occurs again within a few days
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years: consult a doctor
  • Other information

    • store at room temperature
    • you may report a serious adverse reaction to this product to 1-866-651-3660
  • Inactive ingredients

    glycerin, hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxynol 9, PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, triethanolamine, water

  • Questions?

    1-866-651-3660
    Mon-Fri 8:00am-5:00pm EST

  • Package Label - Principal Display Panel

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    AMERICAN SAFETY FIRST AID 
    lidocaine hcl spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71927-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71927-012-0159.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/03/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/03/2022
    Labeler - Orazen Inc (080916640)
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